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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
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BECTON DICKINSON MEDICAL (SINGAPORE) BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE Back to Search Results
Catalog Number 301746
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2022
Event Type  malfunction  
Event Description
It was reported when using the bd vacutainer® flashback blood collection needle it was found that the connection between the needle and the handle of the blood collection device was leaking.The following information was provided by the initial reporter.The customer stated: "during the collection, it was found that the connection between the needle and the handle of the blood collection device was leaking blood and air, which could not be used, and the operation was successfully completed.Blood and air leakage from blood collection device contaminate nurses' operating gloves, increasing the risk of occupational exposure injury for medical personnel.¿.
 
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Event Description
It was reported when using the bd vacutainer® flashback blood collection needle it was found that the connection between the needle and the handle of the blood collection device was leaking.The following information was provided by the initial reporter.The customer stated: "during the collection, it was found that the connection between the needle and the handle of the blood collection device was leaking blood and air, which could not be used, and the operation was successfully completed.Blood and air leakage from blood collection device contaminate nurses' operating gloves, increasing the risk of occupational exposure injury for medical personnel.".
 
Manufacturer Narrative
Investigation summary: material #: 301746; lot/batch #: 2084150.Bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.
 
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Brand Name
BD VACUTAINER® FLASHBACK BLOOD COLLECTION NEEDLE
Type of Device
BLOOD COLLECTION NEEDLE
Manufacturer (Section D)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer (Section G)
BECTON DICKINSON MEDICAL (SINGAPORE)
30 tuas avenue 2
singapore
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15870159
MDR Text Key307815365
Report Number8041187-2022-00684
Device Sequence Number1
Product Code JKA
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/15/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date03/31/2024
Device Catalogue Number301746
Device Lot Number2084150
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/08/2022
Initial Date FDA Received11/28/2022
Supplement Dates Manufacturer Received11/28/2022
Supplement Dates FDA Received07/19/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured05/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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